Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures

Trial Title: Validate the Safety and Feasibility of the CT-guided Interventional Robot in Percutaneous Lung Cryablation Procedures

NCT ID: NCT06581107

Condition: Lung Cancer
Thoracic Cancer

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Image-guided Biopsy; Robot-assisted procedures

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: CT-fluoroscopy guided master-slave intervetional robot-assisted lung Cryoablation
Description: During the procedure, the participants first undergo a CT scan. The radiologist plans the trajectories based on the registered preoperative CECT (contrast-enhanced computed tomography) and intraoperative CT. All participants then undergo navigation, localization, and establishment of cryoprobe trajectories using the interventional master-slave system. On the day of the procedure, the number of needle adjustments, number of cryoprobes used, puncture time, ablation time, and procedure time are recorded. The performance of the research device is evaluated by the radiologists. Postoperative complications of the participants are recorded 7±1 days postoperatively/on the day of discharge based on the postoperative CT scan (whichever comes first).
Arm group label: Singel arm

Summary: This study aims to investigate whether the interventional robot can be well and safely used for percutaneous lung cryoablation in patients with lung cancer. The robot allows radiologists to remotely control the needle insertion process under CT fluoroscopy guidance. The main questions this study aims to answer are: 1. Whether the robot-assisted Cryoablation method can achieve complete the coverage of preoperatively planned ablation areas; 2. Whether the robot-assisted Cryoablation method can improve the success rate for radiologists to insert the needle into the target lesion area without additional needle adjustment; 3. Whether the robot-assisted Cryoablation method can reduce puncture time, ablation time and procedure time; 4. Whether the robot-assisted Cryoablation method can decrease the patient's complication occurrence rate; 5. Whether the robot-assisted Cryoablation method can obtain decent Evaluation of system performance.

Detailed description: Lung cancer is the leading cause of morbidity and mortality of malignant tumors. The surgical resection of lung lobes is the standard treatment for stage I non-small cell lung cancer (NSCLC), with proven long-term cure rates and survival. However, more than 20% of patients are not eligible for surgical treatment due to comorbidities or poor underlying lung reserve. With the development of minimally invasive interventional field, lung cancer cryoablation has also become an established tool for the treatment of early stage lung cancer and palliative treatment of advanced lung cancer in recent years. However, the image-guidance cryoablation method still faces the following challenges: 1. Lack of real-time and accurate information during the needle insertion process, including puncture force, needle deformation, soft tissue deformation, and needle arrival position; 2. Multiple scans during the puncture are needed to determine whether the needle has successfully reached the target area, which leads to prolonged operation time, easily induces complications and increases the radiation dose to the physicians. 3. The accuracy of needle insertion is highly affected by the patient's respiration movement causing the multi-directional nonlinear displacement and deformation of tissues and organs (movement, rotation, etc.), resulting in the drift of the tumour position. Eventually, it is difficult for radiologists to reach the target position, resulting in insufficient ablation areas and increased probability of cancer recurrence. 4. The physiological trembling of the radiologist's hand will reduce the accuracy of puncture, and even lead to complications such as bleeding and pneumothorax 5. The procedure is highly dependent on the ability and experience of radiologists.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Participants suffering from lung cancer and judged by the investigator to be indicated for cryoablation procedures; 2. Participants voluntarily participate in this clinical study and sign the informed consent form; 3. Participants cannot undergo surgical treatment due to contraindications to surgical resection of lung cancer; 4. Participants can understand the study and cooperate with the study procedures, and are able to carry out follow-up observation as required. Exclusion Criteria: 1. Participants have diffuse lesions in both lungs that cannot be improved by ablative therapy; 2. Participants suffer from extensive pleural metastases with massive pleural effusion; 3. Participants have tumors adjacent to the mediastinal blood vessels, contrast allergy, or inability to cooperate, which makes it difficult to choose the route of needle insertion; 4. Participants with lesions encircling blood vessels where ablation may lead to severe bleeding; 5. Participants with severely impaired lung function, with maximal ventilation <40%; 6. Participants with a low platelet count and severe coagulation abnormalities who cannot tolerate the procedure (anticoagulant therapy and/or anticoagulant medication should be discontinued for more than 1 week prior to ablation therapy); 7. Participants with poor general condition (multiple metastases throughout the body, severe infections, high fever), obvious malignant disease, severe insufficiency of vital organ function, severe anemia, and disorders of nutritional metabolism that cannot be improved in the short term; 8. Allergy to contrast media or anesthetics; 9. Pregnant or breastfeeding women, or those who plan to have children during the clinical study; 10. Participants with known addiction to drugs, alcohol, etc.; 11. Participants with psychiatric disorders who have no self-control and are unable to communicate clearly; 12. Participants who have participated in other drug, biologic, or medical device clinical studies without meeting the primary study endpoint timeframe prior to enrollment in this study; 13. Any other conditions that the investigator deems unsuitable for participation in this clinical study.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tianjin Medical University, Cancer Institute & Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Contact:
Last name: Haipeng Yu, PhD

Phone: 0086-22-23340123
Email: jieruke@163.com

Contact backup:
Last name: Xueling Yang, PhD

Phone: 0086-22-23340123
Email: yxueling123@163.com

Investigator:
Last name: Haipeng Yu, PhD
Email: Sub-Investigator

Investigator:
Last name: Xueling Yang, PhD
Email: Sub-Investigator

Start date: September 15, 2024

Completion date: February 28, 2025

Lead sponsor:
Agency: Tianjin Medical University Cancer Institute and Hospital
Agency class: Other

Collaborator:
Agency: Wuhan United Imaging Surgical co., ltd.
Agency class: Other

Source: Tianjin Medical University Cancer Institute and Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06581107